Reliability of Home Uroflowmetery Using a Disposable Digital Device in Comparison to Standard Clinical Uroflowmetry in Men With LUTS
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Usability evaluation of the FloRite™ system with LUTS patients.
研究概览
简要总结
The FloRite™ device is a disposable urine flow meter, indicated for use in a home setting.
The device provides Urofowmetry measurements, similar to clinic's measurements. Clinic-based uroflowmetry has some flaws; the setting is artificial and often it is difficult to void at the desired moment. Moreover, a single measurement of the voided parameters is a poor representative of the patient condition due to high variability of the measured parameters. Performing multiple Urofowmetry measurements provides representative and more accurate results, in a more patient-friendly, cost effective method.
详细描述
The FloRite™ product is a disposable urine flow meter. The patient needs to urinate into the device and at the end of urination the patient needs to disconnect a USB drive from the device, dispose the device's container and keep the USB drive that contains the test data.
Primary objectives:
• Usability evaluation of the FloRite™ system with LUTS patients.
Secondary objectives:
- Comparison of uroflowmetric parameters obtained using home disposable digital uroflowmetry device with standard clinic-based uroflowmetry.
- Evaluation of diurnal variations in uroflowmetric parameters obtained using home uroflowmetry
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •LUTS patients
- •Male 18<Age <65
- •Ability to speak, read and understand instructions
- •Patient willing to sign an Informed Consent
- •Exclusion criteria:
- •Mentally disabled patients
- •Infectious diseases
- •Catheterized patients
- •Buried penis due to obesity
排除标准
- 未提供
结局指标
主要结局
Usability evaluation of the FloRite™ system with LUTS patients.
时间窗: Dec-2014
Primary outcome measures • Successful use of FloRite™ system in LUTS patients, defined as: * Successful unpacking and installation * Successful understanding of the user manual * Ability of the patients to operate the device as define by a successful test completion and data transmission * Successful retrieval of the DOK * Absence of: * Device dropping down * Urination outside the container * Urination on the electronic unit
次要结局
- Comparison of Qmax (Max Flow Rate)(Dec-2014)
- Comparison of Tdelay(Dec-2014)
- Comparison of uroflowmetric parameter: T100 - Voiding Time(Dec-2014)
- Comparison of uroflowmetric parameters of TQ - Flow Time(Dec-2014)
- Comparison of uroflowmetric parameters of Tqmax - Time to max Flow(Dec-2014)
- Comparison of uroflowmetric parameters of Qave(Dec-2014)
- Comparison of uroflowmetric parameters of Vcomp - Voided volume(Dec-2014)